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A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma


N/A
17 Years
N/A
Not Enrolling
Both
Osteolymphoma

Thank you

Trial Information

A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma


Patients with non-Hodgkin's lymphoma arising primarily in bone have been studied using a
number of different names making literature searching difficult. The term Osteolymphoma has
been proposed to make searching easier in the future. Patients in this study undergoing
staging which includes isotope bone scanning and PET scanning where available. Eligible
patients then undergo treatment with three cycles of CHOP chemotherapy at conventional doses
and shrinking field radiotherapy to a total of 45 Gy. Monoclonal antibodies are not included
as good results have been obtained without using them. After treatment the patients are
regularly monitored. The trial is presented twice per year at the meetings of TROG, ALLG and
AROLG.


Inclusion Criteria:



- Histologically confirmed non-Hodgkin's lymphoma in a bony site

- Limited extraosseous disease

- Ann Arbor stage IE

- Age >17

- ECOG performance status <3

- Expected survival > 6 months

- Patients capable of childbearing are using adequate contraception.

- Written informed consent

Exclusion Criteria:

- Previous radiotherapy

- Previous malignancy

- Medically unfit to undergo treatment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival. The time from registration to the date of death

Outcome Time Frame:

Main analysis when accrual is complete at approx. 10 years.

Safety Issue:

No

Principal Investigator

David Christie, FRANZCR

Investigator Role:

Study Chair

Investigator Affiliation:

East Coasr Cancer Centre

Authority:

Australia: Human Research Ethics Committee

Study ID:

TROG 99.04

NCT ID:

NCT00141648

Start Date:

September 2000

Completion Date:

February 2008

Related Keywords:

  • Osteolymphoma
  • Osteolymphoma
  • Chemotherapy
  • Radiotherapy
  • Lymphoma

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